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Resource issues, Poor recruitment
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This study aims to determine whether Entonox (gas and air) is at least as good as intravenous midazolam in providing analgesia and sedation during gastroscopy. Entonox is used as an adjunct in lower gastrointestinal procedures but is not routinely used in gastroscopy, and there is only one similar published study to date, which was performed in children. The main advantage of Entonox over midazolam is the quick recovery time following withdrawal of the agent, which enables patients to return to independent normal life. The investigators would like to be able to offer Entonox to patients as an option for sedation during gastroscopy, this study is being conducted to determine if it is a safe and feasible option.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam | Active Comparator | midazolam sedation combined with pharyngeal anaesthesia Participants randomized to receive midazolam will have an intravenous cannula sited and, following the administration of xylocaine throat spray as above, will be put into the left lateral position. They will then be given up to 5mg midazolam as appropriate to achieve conscious sedation as for standard protocol in endoscopy. |
|
| Entonox | Experimental | Entonox combined with pharyngeal anaesthesia. Pharyngeal anaesthesia, given as 8-16 sprays of xylocaine to the pharynx; 3 minutes will be given to allow the pharynx to become anaesthetized. Participants randomized to receive Entonox will be given the 50:50 nitrous oxide:oxygen mix via a mouthpiece with a demand valve system, once in position for the procedure. Inhalations will be given for 3-5 minutes (or until the participant feels adequately sedated) measured using a stopwatch. Oxygen will be given at 2 litres per minute via nasal cannulae during the procedure, (standard care for sedated procedures). The endoscopist will then proceed to intubate the cricopharynx and perform the procedure in the standard manner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entonox | Drug | Entonox arm |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Mild or no Discomfort During Gastroscopy | Percentage of patients with a score of 4 or 5 on the 5-point modified global rating scale comfort score, as measured by the patient, will be compared between the midazolam and entonox groups, per protocol. The comfort score ranges from 1-5 with 1 meaning patient was in extreme discomfort frequently during procedure and 5 being no discomfort, resting comfortably throughout. The score is completed by the patient while they are in the recovery area post procedure and prior to discharge from the unit. | During gastroscopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Completed Procedures in Both Arms of the Study. | The percentage of participants with completed procedures in both arms of the study confirmed by data collection. | Day of procedure |
| Comparison of Procedure Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon McLaughlin, MD | The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust | Bournemouth | Dorset | BH7 7DW | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Midazolam | midazolam sedation combined with pharyngeal anaesthesia Participants randomized to receive midazolam will have an intravenous cannula sited and, following the administration of xylocaine throat spray as above, will be put into the left lateral position. They will then be given up to 5mg midazolam as appropriate to achieve conscious sedation as for standard protocol in endoscopy. Midazolam: up to 5mg midazolam as appropriate |
| FG001 | Entonox | Entonox combined with pharyngeal anaesthesia. Pharyngeal anaesthesia, given as 8-16 sprays of xylocaine to the pharynx; 3 minutes will be given to allow the pharynx to become anaesthetized. Participants randomized to receive Entonox will be given the 50:50 nitrous oxide:oxygen mix via a mouthpiece with a demand valve system, once in position for the procedure. Inhalations will be given for 3-5 minutes (or until the participant feels adequately sedated) measured using a stopwatch. Oxygen will be given at 2 litres per minute via nasal cannulae during the procedure, (standard care for sedated procedures). The endoscopist will then proceed to intubate the cricopharynx and perform the procedure in the standard manner. Entonox: Entonox arm |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Midazolam | midazolam sedation combined with pharyngeal anaesthesia Participants randomized to receive midazolam will have an intravenous cannula sited and, following the administration of xylocaine throat spray as above, will be put into the left lateral position. They will then be given up to 5mg midazolam as appropriate to achieve conscious sedation as for standard protocol in endoscopy. Midazolam: up to 5mg midazolam as appropriate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age was not collected. All participants were 18 or over to be eligible for the study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Mild or no Discomfort During Gastroscopy | Percentage of patients with a score of 4 or 5 on the 5-point modified global rating scale comfort score, as measured by the patient, will be compared between the midazolam and entonox groups, per protocol. The comfort score ranges from 1-5 with 1 meaning patient was in extreme discomfort frequently during procedure and 5 being no discomfort, resting comfortably throughout. The score is completed by the patient while they are in the recovery area post procedure and prior to discharge from the unit. | Posted | Number | percentage of participants | During gastroscopy procedure |
|
From participant consent until 72 hours post procedure. Adverse events were monitored while the patient was on site following consent until they were discharged from the endoscopy unit. A follow up phone call was completed 72 hours after the participant was discharged and the participants were asked to recall any adverse events that have occurred since their discharge.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Midazolam | midazolam sedation combined with pharyngeal anaesthesia Participants randomized to receive midazolam will have an intravenous cannula sited and, following the administration of xylocaine throat spray as above, will be put into the left lateral position. They will then be given up to 5mg midazolam as appropriate to achieve conscious sedation as for standard protocol in endoscopy. Midazolam: up to 5mg midazolam as appropriate |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Allergic reaction to cannula plaster |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Simon McLaughlin | University Hospitals Dorset NHS Foundation Trust | 01202303626 | Simon.McLaughlin@uhd.nhs.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2019 | Mar 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C001147 | Entonox |
| D010100 | Oxygen |
| D009609 | Nitrous Oxide |
| D008874 | Midazolam |
| D012996 | Solutions |
| D007267 | Injections |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D009589 |
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| Midazolam | Drug | up to 5mg midazolam as appropriate |
|
|
Comparison of procedure time, defined as start time to end time in the per protocol population, between the two groups.
| Defined as start time to end time of gastroscopy. |
| Comparison of Procedure Start Time to Discharge. | Comparison of gastroscopy procedure start time to discharge from endoscopy department post-procedure care time in the per protocol population between the two groups. | Procedure to discharge |
| Number of Patients With Adverse Events. | Number of patients reporting adverse events. | Consent to 72 hours post discharge from the endoscopy unit which is the same day as the procedure. |
| Comparison of Visual Analogue Scale Scores. | Comparison of VAS (Visual Analogue Scale) scores between the two groups (per protocol). The scale ranges between 0 and 100 where 0 is the worst imaginable experience and 100 being very comfortable. The visual measure is a 100mm line and the score is measured by the participant marking on the line how they felt the procedure was. The research team then measure the line and confirm the score to the nearest mm to get a score of 0-100. | Completed after procedure completion during the post-procedure care and prior to discharge from the endoscopy unit. |
| 5-point Modified Global Rating Scale Comfort Nurse Score | Percentage of patients with a score of 4 or 5 on the 5-point comfort scale, as measured by the endoscopy nurse, will be compared between the midazolam and Entonox groups, per protocol. The comfort score ranges from 1-5 with 1 meaning patient was in extreme discomfort frequently during procedure and 5 being no discomfort, resting comfortably throughout. This score is completed by the endoscopy nurse immediately following the patients procedure. | Completed after procedure completion during the post-procedure care and prior to discharge from the endoscopy unit. |
| BG001 | Entonox | Entonox combined with pharyngeal anaesthesia. Pharyngeal anaesthesia, given as 8-16 sprays of xylocaine to the pharynx; 3 minutes will be given to allow the pharynx to become anaesthetized. Participants randomized to receive Entonox will be given the 50:50 nitrous oxide:oxygen mix via a mouthpiece with a demand valve system, once in position for the procedure. Inhalations will be given for 3-5 minutes (or until the participant feels adequately sedated) measured using a stopwatch. Oxygen will be given at 2 litres per minute via nasal cannulae during the procedure, (standard care for sedated procedures). The endoscopist will then proceed to intubate the cricopharynx and perform the procedure in the standard manner. Entonox: Entonox arm |
| BG002 | Total | Total of all reporting groups |
Age was not collected. All participants were 18 or over to be eligible for the study.
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Gender data was not collected. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Entonox | Entonox combined with pharyngeal anaesthesia. Pharyngeal anaesthesia, given as 8-16 sprays of xylocaine to the pharynx; 3 minutes will be given to allow the pharynx to become anaesthetized. Participants randomized to receive Entonox will be given the 50:50 nitrous oxide:oxygen mix via a mouthpiece with a demand valve system, once in position for the procedure. Inhalations will be given for 3-5 minutes (or until the participant feels adequately sedated) measured using a stopwatch. Oxygen will be given at 2 litres per minute via nasal cannulae during the procedure, (standard care for sedated procedures). The endoscopist will then proceed to intubate the cricopharynx and perform the procedure in the standard manner. Entonox: Entonox arm |
|
|
| Secondary | Number of Participants With Completed Procedures in Both Arms of the Study. | The percentage of participants with completed procedures in both arms of the study confirmed by data collection. | Posted | Number | Percentage of participants | Day of procedure |
|
|
|
| Secondary | Comparison of Procedure Time | Comparison of procedure time, defined as start time to end time in the per protocol population, between the two groups. | Posted | Median | Full Range | Minutes | Defined as start time to end time of gastroscopy. |
|
|
|
| Secondary | Comparison of Procedure Start Time to Discharge. | Comparison of gastroscopy procedure start time to discharge from endoscopy department post-procedure care time in the per protocol population between the two groups. | Posted | Median | Full Range | Minutes | Procedure to discharge |
|
|
|
| Secondary | Number of Patients With Adverse Events. | Number of patients reporting adverse events. | Posted | Count of Participants | Participants | Consent to 72 hours post discharge from the endoscopy unit which is the same day as the procedure. |
|
|
|
| Secondary | Comparison of Visual Analogue Scale Scores. | Comparison of VAS (Visual Analogue Scale) scores between the two groups (per protocol). The scale ranges between 0 and 100 where 0 is the worst imaginable experience and 100 being very comfortable. The visual measure is a 100mm line and the score is measured by the participant marking on the line how they felt the procedure was. The research team then measure the line and confirm the score to the nearest mm to get a score of 0-100. | 1 participant in the Midazolam cohort did not complete the Visual Analogue Scale post procedure prior to discharge. | Posted | Median | Full Range | score on a scale | Completed after procedure completion during the post-procedure care and prior to discharge from the endoscopy unit. |
|
|
|
| Secondary | 5-point Modified Global Rating Scale Comfort Nurse Score | Percentage of patients with a score of 4 or 5 on the 5-point comfort scale, as measured by the endoscopy nurse, will be compared between the midazolam and Entonox groups, per protocol. The comfort score ranges from 1-5 with 1 meaning patient was in extreme discomfort frequently during procedure and 5 being no discomfort, resting comfortably throughout. This score is completed by the endoscopy nurse immediately following the patients procedure. | Posted | Count of Participants | Participants | Completed after procedure completion during the post-procedure care and prior to discharge from the endoscopy unit. |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 1 |
| 32 |
| EG001 | Entonox | Entonox combined with pharyngeal anaesthesia. Pharyngeal anaesthesia, given as 8-16 sprays of xylocaine to the pharynx; 3 minutes will be given to allow the pharynx to become anaesthetized. Participants randomized to receive Entonox will be given the 50:50 nitrous oxide:oxygen mix via a mouthpiece with a demand valve system, once in position for the procedure. Inhalations will be given for 3-5 minutes (or until the participant feels adequately sedated) measured using a stopwatch. Oxygen will be given at 2 litres per minute via nasal cannulae during the procedure, (standard care for sedated procedures). The endoscopist will then proceed to intubate the cricopharynx and perform the procedure in the standard manner. Entonox: Entonox arm | 0 | 30 | 0 | 30 | 2 | 30 |
|
| Blurred Vision | Eye disorders | Non-systematic Assessment |
|
| Shivering | Nervous system disorders | Non-systematic Assessment |
|
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| Nitrogen Oxides |
| D017672 | Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |